Gingival RecessionNCT02129504
Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix
A study testing root coverage comparing two techniques in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- root coverage comparing two techniques
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 25 to 50 years old
- bilateral gingival recession type Miller class I or II
- with 3 mm in height and less than 3mm of keratinized tissue
- non-molar teeth
Who cannot join
- diabetics
- pregnant women
- chronic use of medication
- periodontitis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of dentistry of Ribeirão Preto
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.
Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.
- Conditions
- Gingival Recession
- Being tested
- root coverage comparing two techniques
- Keywords
- root coverage, gingival recession, periodontal surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root coverage comparing two techniquesDevice
Also called Mucograft, porcine collagen matrix, extended flap technique, coronal advanced flap technique
The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.
| Study group | Role | What they receive |
|---|---|---|
| coronal advanced technique | Experimental | root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique) Receives: Device: root coverage comparing two techniques |
| extended flap technique | Experimental | root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique) Receives: Device: root coverage comparing two techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months
At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter.
Measured: Change from Baseline at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Belem Novaes Jr, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129504
- Sponsor's protocol ID
- PCM
- Status last verified
- May 2014
- First submitted
- 29 Apr 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.
PubMed 20350159
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.
- ClinicalTrials.gov ID
- NCT02129504
- Acronym / sponsor ID
- PCM
- Conditions
- Gingival Recession
- Keywords
- root coverage, gingival recession, periodontal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronal advanced technique | Experimental | Device: root coverage comparing two techniquesroot coverage with the porcine collagen matrix using the coronal advanced technique (standard technique) |
| extended flap technique | Experimental | Device: root coverage comparing two techniquesroot coverage with the porcine collagen matrix using the extended flap technique (new surgical technique) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ages 25 to 50 years old
- bilateral gingival recession type Miller class I or II
- with 3 mm in height and less than 3mm of keratinized tissue
- non-molar teeth
Key exclusion criteria (4 listed)
- diabetics
- pregnant women
- chronic use of medication
- periodontitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| root coverage comparing two techniquesAlso: Mucograft, porcine collagen matrix, extended flap technique, coronal advanced flap techniqueThe aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage. | Device | coronal advanced technique, extended flap technique |
Primary outcome
Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months
Time frame: Change from Baseline at 3, 6 and 12 months
At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Background: PubMed 20350159McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root coverage comparing two techniques in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months (time frame: Change from Baseline at 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2014; AzTrials last refreshed its copy on 27 Oct 2026.